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FDA finds no additional safety concerns with Breo Ellipta
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GlaxoSmithKline’s Breo Ellipta showed no new safety concerns while being tested to treat asthma, according to a preliminary review from the FDA.
Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) is a fixed-dose combination administered by oral inhalation. Its safety will come into question when two FDA advisory committees meet Thursday to consider its approval for treating patients with asthma.
The drug combination already is approved for the treatment of COPD.
In the review, the FDA wrote that there were no deaths associated with Breo Ellipta in an asthma exacerbation study that compared the combination drug with fluticasone furoate for treatment duration up to 76 weeks.
Serious adverse events occurred with limited frequency in the clinical studies, and there were no new safety signals identified, based on the evaluation of the serious adverse events.
Adverse events were typical of other asthma studies, the FDA wrote; they included oropharyngeal pain, oral candidiasis, dysphonia, and tremor.
Healio.com/Allergy will provide developments from Thursday’s FDA advisory committee meeting. –by Ryan McDonald